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Sign in to claim this brandNIDACON INTERNATIONAL AB
Sweden·SE-MF-000001933
Last updated September 17, 2026
What NIDACON INTERNATIONAL AB makes
Nidacon International AB manufactures a range of products for assisted reproduction, including sperm preparation media, density gradient centrifugation solutions, and cryoprotectants. Their portfolio also features specialized devices such as embryo transfer catheters, vitrification and warming systems, and tools for sperm selection and analysis.
The company is based in Sweden and maintains a portfolio of devices classified as Class II and Class III. These products are listed in the EUDAMED database and have received FDA 510(k) clearance for use in clinical settings.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of products does Nidacon International AB manufacture?
Nidacon International AB specializes in the production of medical devices for assisted reproduction. Their product portfolio includes sperm preparation media, density gradient centrifugation solutions, and cryoprotectants. Additionally, they manufacture specialized tools for clinical use, such as embryo transfer catheters, vitrification and warming systems, and devices designed for sperm selection and analysis.
Where is Nidacon International AB located?
Nidacon International AB is based in Sweden. This location serves as the primary base for the company's operations and the development of their assisted reproduction technologies.
How are the devices from Nidacon International AB classified and where are they listed?
The devices manufactured by Nidacon International AB are classified as Class II and Class III medical devices. These products are officially listed in the EUDAMED database and have received FDA 510(k) clearance, which confirms their authorization for use in clinical settings.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- Sweden
- Address
- 16B, Flöjelbergsgatan , Mölndal, Sweden
- Website
- www.nidacon.com
- —
- —
- [email protected]
- Phone
- +46 31 7030630
- PRRC Contact
- Magda Alic Holmes
- EUDAMED SRN
- SE-MF-000001933
- FDA FEI Number
- 3004848623
- DUNS Number
- —
Catalogue (20)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| NidOil | NO-100 | EUDAMEDFDA UDI | Class III | Active |
| Proinsert | K131145 | FDA 510(k) | Class II | Active |
| Spermcatch | K011607 | FDA 510(k) | Class II | Active |
| Modification Of Puresperm | K984172 | FDA 510(k) | Class II | Active |
| Vitriblast, Thermoblast, Model Vb-010, Tb-010 | K092107 | FDA 510(k) | Class II | Active |
| Puresperm 40 And Puresperm 80 | K002623 | FDA 510(k) | Class II | Active |
| Readyswim | K011346 | FDA 510(k) | Class II | Active |
| Spermassist | K022443 | FDA 510(k) | Class II | Active |
| SpermCryoProtec | SCP-020 | EUDAMEDFDA UDI | Class III | Active |
| PureSperm 100 | PS100-100 | EUDAMEDFDA UDI | Class III | Active |
| PureSperm 90 | PS90-100 | EUDAMED | Class III | Active |
| PureSperm 100 | PS100-1000K | EUDAMEDFDA UDI | Class III | Active |
| PureSperm 40/80 | PSK-020 | EUDAMEDFDA UDI | Class III | Active |
| PureSperm Wash | PSW-020 | EUDAMEDFDA UDI | Class III | Active |
| PureSperm Buffer | PSB-100 | EUDAMEDFDA UDI | Class III | Active |
| PureSperm 100 | PS100-250 | EUDAMEDFDA UDI | Class III | Active |
| PureSperm 80 | PS80-100 | EUDAMEDFDA UDI | Class III | Active |
| PureSperm 40 | PS40-100 | EUDAMEDFDA UDI | Class III | Active |
| NidOil | NO-400 | EUDAMEDFDA UDI | Class III | Active |
| PureSperm Wash | PSW-100 | EUDAMEDFDA UDI | Class III | Active |
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FDA Establishments (1)
Establishments registered with the FDA under this company group, matched by name.
- Nidacon International AB US